Trial Outcomes & Findings for Combination Versus Laser Treatment Only (NCT NCT03661697)
NCT ID: NCT03661697
Last Updated: 2020-04-24
Results Overview
Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
baseline to 12 weeks
Results posted on
2020-04-24
Participant Flow
Participant milestones
| Measure |
Lytera Arm
4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
Placebo Arm
4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Basic Skin Care Regimen Only and Laser Therapy: Not Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Versus Laser Treatment Only
Baseline characteristics by cohort
| Measure |
Lytera Arm
n=7 Participants
4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
Placebo Arm
n=7 Participants
4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Basic Skin Care Regimen Only and Laser Therapy: Not Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.43 years
n=5 Participants
|
51.57 years
n=7 Participants
|
49.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksBlinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)
Outcome measures
| Measure |
Lytera Arm
n=7 Participants
4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
Placebo Arm
n=7 Participants
4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Basic Skin Care Regimen Only and Laser Therapy: Not Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
|---|---|---|
|
Change in Aesthetics
|
2 score on a scale
Interval 1.5 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: baseline to 12 weeksChange in skin tone is assessed using the Modified Pigmentation Area and Severity Index (MoPASI). MoPASI assesses three facial region variables: 1) A = % area of involvement (0 = no involvement, 6 = 90% involvement), 2) D = darkness of pigment (0=absent, 4=maximum), 3) P = pattern of involvement (0=absent, 4=maximum). Four facial regions will be assessed: Forehead (0.2A), Left Cheek and periorbital (0.3A), Right Cheek and periorbital (0.3A), Nose/Lip/Chin (0.2A). The Total score ranges from 0-48 and is calculated using the formula: MoPASI = 0.2A(D + P) + 0.3A (D+P) + 0.3A (D+P) + 0.2A (D+P). A higher score indicates higher pigmentation.
Outcome measures
| Measure |
Lytera Arm
n=7 Participants
4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
Placebo Arm
n=7 Participants
4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Basic Skin Care Regimen Only and Laser Therapy: Not Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
|---|---|---|
|
Change in Skin Tone
|
-8.7 score on a scale
Interval -10.8 to -6.55
|
-3.90 score on a scale
Interval -4.3 to -2.95
|
Adverse Events
Lytera Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lytera Arm
n=7 participants at risk
4 week washout period with skin care regimen (facial cleanser, Lytera 2.0, TNS Ceramide Treatment Cream and Essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Skin Care Regimen plus Lytera 2.0 and Laser Therapy: Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
Placebo Arm
n=7 participants at risk
4 week washout period with a basic skin care regimen (facial cleanser, TNS Ceramide Treatment Cream and essential defense mineral shield broad spectrum SPF 35) followed by 2 laser treatments.
Basic Skin Care Regimen Only and Laser Therapy: Not Combined
Lytera plus Laser: two arms of study- each with different topical cosmeceutical
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
acne
|
28.6%
2/7 • Number of events 2 • 12 weeks
treatment emergent
|
0.00%
0/7 • 12 weeks
treatment emergent
|
|
Skin and subcutaneous tissue disorders
dryness
|
0.00%
0/7 • 12 weeks
treatment emergent
|
28.6%
2/7 • Number of events 2 • 12 weeks
treatment emergent
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place